Ignite Creation Date:
2024-05-06 @ 8:10 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06284889
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-02-29
First Post:
2024-02-21
Brief Title:
Behavioral Activation for the Treatment of Depression in Older Adults
Sponsor:
Uppsala University
Organization:
Uppsala University
Study Overview
Official Title:
Behavioral Activation for the Treatment of Depression in Older Adults A Randomised Controlled Multicenter Trial in Primary Care DepActive
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DepActive
Brief Summary:
Depression affects between 5-15 of adults 65 years in Sweden Depression in older adults reduces functional ability and quality of life and increases the risk for morbidity loneliness and suicide Psychological treatment is recommended as a first-line treatment for depression which about 3 of older adults with depression in Sweden report receiving One effective psychological treatment is behavioral activation which reduces depressive symptoms by increasing enjoyable meaningful and important activities for example exercise and social activities The research group conducted a pilot study of telephone based behavioral activation for isolated older adults with depression during the COVID-19 pandemic The intervention consisted of four telephone calls and the results showed a significant decrease in depressive symptoms with maintained effects for six months
250 individuals will participate in the study Half of the participants will be randomised to start the intervention immediately while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center Participants will be asked to fill in questionnaires before after treatment Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline post-intervention and after 3-months A smaller group of participants 10-15 will be asked to participate in a more detailed interview about how they experienced the treatment
250 individuals will participate in the study Half of the participants will be randomised to start the intervention immediately while the other half of the participants will be randomized to a control group receiving treatment as usual at their respective primary care center Participants will be asked to fill in questionnaires before after treatment Questionnaires will also be sent 3- and 6 months after treatment to follow up on the results Patients will be asked to wear an accelerometer for 5-7 days to record their activity level at baseline post-intervention and after 3-months A smaller group of participants 10-15 will be asked to participate in a more detailed interview about how they experienced the treatment
Detailed Description:
In Sweden depression among the elderly is a major public health concern Major depression occurred in 5-15 of the older population in Sweden and one third of the women and a fifth of the men 65 years and older reported subclinical depressive symptoms Several mental health experts raise concerns that there will be an increase of psychiatric illness during and after COVID-19 particularly among the elderly
Depression in older individuals can be treated with antidepressant medication psychological interventions and physical activity However the majority of the older individuals state that they would prefer psychological treatments to medication which poses a challenge during COVID-19 as such treatments are often delivered face-to-face Psychological treatments delivered via the Internet are as efficacious as face-to-face but only 3-4 of the individuals 65 years and above in Sweden use digital applications that replace physical healthcare visits
The purpose of this randomised controlled multicenter study is to evaluate the effects and outcomes of a telephone-delivered Behavioral Activation-treatment for older adults with depression in primary care within the framework of the research project DepActive Our study specifically aims to 1 investigate the effect of a telephone-delivered BA-treatment for older adults with depression in primary care with regards to a depressive symptoms primary outcome measure b depression diagnosis c anxiety symptoms d quality of life e activity level f functional ability g cognitive function h loneliness i self-efficacy j cost effectiveness k care consumption including pharmacological treatment 2 explore patients and therapists experiences of the treatment 3 investigate to which extent the BA-treatment corresponds to person-centered care 4 investigate the mediating role of type of activity and level of physical activity with regards to improvement in depressive symptoms 5 investigate whether the intervention impacts the need for community healthcare services for participants utilizing such services
The study is a multi-center randomised controlled clinical trial in primary care in the Swedish county councils of Vastmanland Uppsala and Sormland
Participants will be recruited from multiple primary care centers in each region If the participant is enrolled in the study the study therapist performs the randomisation by using an online randomisation software with a 11 random-blocks sequence The participants are randomised consecutively to two arms control group or intervention group The control group will receive treatment as usual TAU in primary care and the intervention group will receive TAU with the addition of a five-session telephone-based BA-intervention over an eight-week period
Depression in older individuals can be treated with antidepressant medication psychological interventions and physical activity However the majority of the older individuals state that they would prefer psychological treatments to medication which poses a challenge during COVID-19 as such treatments are often delivered face-to-face Psychological treatments delivered via the Internet are as efficacious as face-to-face but only 3-4 of the individuals 65 years and above in Sweden use digital applications that replace physical healthcare visits
The purpose of this randomised controlled multicenter study is to evaluate the effects and outcomes of a telephone-delivered Behavioral Activation-treatment for older adults with depression in primary care within the framework of the research project DepActive Our study specifically aims to 1 investigate the effect of a telephone-delivered BA-treatment for older adults with depression in primary care with regards to a depressive symptoms primary outcome measure b depression diagnosis c anxiety symptoms d quality of life e activity level f functional ability g cognitive function h loneliness i self-efficacy j cost effectiveness k care consumption including pharmacological treatment 2 explore patients and therapists experiences of the treatment 3 investigate to which extent the BA-treatment corresponds to person-centered care 4 investigate the mediating role of type of activity and level of physical activity with regards to improvement in depressive symptoms 5 investigate whether the intervention impacts the need for community healthcare services for participants utilizing such services
The study is a multi-center randomised controlled clinical trial in primary care in the Swedish county councils of Vastmanland Uppsala and Sormland
Participants will be recruited from multiple primary care centers in each region If the participant is enrolled in the study the study therapist performs the randomisation by using an online randomisation software with a 11 random-blocks sequence The participants are randomised consecutively to two arms control group or intervention group The control group will receive treatment as usual TAU in primary care and the intervention group will receive TAU with the addition of a five-session telephone-based BA-intervention over an eight-week period
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None